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NCT04379050 · ClinicalTrials.gov registry record · Phase 3
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
A Phase 3 study of Parkinsons Disease (PD), sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT04379050 is a Phase 3 study of Parkinsons Disease (PD) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 130 participants, above the 113-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT04379050, a Phase 3 study of Parkinsons Disease (PD), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741. ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide. Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Conditions Studied
Interventions
- DRUG ABBV-951
Study Locations (20)
Texas
- Baylor College of Medicine /ID# 215401 - Houston
- Central Texas Neurology Consul /ID# 217013 - Round Rock
- Univ Texas HSC San Antonio /ID# 215400 - San Antonio
Washington
- Booth Gardner Parkinson's Care Center /ID# 215535 - Kirkland
- Inland Northwest Research /ID# 215533 - Spokane
New South Wales
- Concord Repatriation General Hospital /ID# 215943 - Concord
- Westmead Hospital /ID# 215941 - Westmead
Alabama
- University of Alabama at Birmingham - Main /ID# 215597 - Birmingham
Arizona
- Banner Sun Health Research Institute /ID# 215579 - Sun City
Colorado
- University of Colorado Hospital /ID# 215625 - Aurora
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412 - Boca Raton
Indiana
- Indiana Clinical Research Cent /ID# 216490 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04379050
The ClinicalTrials.gov registry entry for NCT04379050 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 113-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (15% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 1 intervention - of which ABBV-951 is the first listed.
NCT04379050 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Texas, Washington, New South Wales.
Frequently Asked Questions
What is clinical trial NCT04379050 about?
NCT04379050 is a clinical study titled "Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease". Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABB...
What is the current status of trial NCT04379050?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2020-06-08. Estimated completion is 2026-04.
What conditions does trial NCT04379050 study?
This clinical trial studies the following conditions: Parkinsons Disease (PD).
What interventions are being tested in trial NCT04379050?
The interventions under investigation include: ABBV-951 (DRUG).
Who is sponsoring clinical trial NCT04379050?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04379050 being conducted?
This trial has 20 study locations across Alabama, Arizona, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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